The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005

Obligations of holders of traditional herbal registrations, and offences by holders of traditional herbal registrations and other persons

9.—(1) Every holder of a traditional herbal registration for a traditional herbal medicinal product shall comply with all obligations which relate to him by virtue of the relevant Community provisions including, in particular, obligations relating to providing or updating information, to making changes, to applying to vary the traditional herbal registration, to pharmacovigilance, and to labels and package leaflets.

(2) The holder of a traditional herbal registration shall maintain a record of reports of which he is aware of suspected adverse reactions in accordance with the relevant Community provisions which shall be open to inspection by a person authorised by the licensing authority, who may take copies of the record and, if the licensing authority so directs, the registration holder shall furnish the licensing authority with a copy of any such reports of which he has a record or of which he is or subsequently becomes aware.

(3) The holder of a traditional herbal registration shall keep such documents as will facilitate the withdrawal or recall from sale or supply of any traditional herbal medicinal product to which the registration relates.

(4) The holder of a traditional herbal registration shall notify the licensing authority if the medicinal product to which the registration relates has not been placed on the market in the United Kingdom for a period of three consecutive years.

(5) The holder of a traditional herbal registration shall, on request from the licensing authority, provide the licensing authority with data on the volume of sales of the medicinal product to which the registration relates.

(6) Schedule 3 shall have effect to create certain criminal offences in connection with the obligations of applicants for, and holders of, traditional herbal registrations and other persons arising under the relevant Community provisions.

(7) Where, by or under any provision of the relevant Community provisions or of these Regulations, a person is required to provide any information or furnish any document to the licensing authority and no time is specified in that provision within which that obligation is to be performed, it shall be performed within such time as may be specified in a written notice served on that person by the licensing authority.